AnthraxFDA considers placing anthrax kits in American households

Published 10 April 2012

The FDA is examining distributing anthrax med kits to 114 million American households; the agency is concerned about the possible misuse of the kits, and about whether their distribution would lead people to believe an anthrax attack was imminent, causing panic

The U.S. Food and Drug Administration (FDA) is reviewing the efficacy and possible detriments of placing anthrax antidote kits in 114 million American homes.

The agency is focusing on two issues:  whether the kits themselves may be misused by members of the public who receive them, and whether the distribution of the kits may the cause of panic among the public.

The kits consist of a 10-day supply of doxycycline, a common antibiotic, which should be made available to all Americans to store in their homes in case of an anthrax attack. Doxycycline works by preventing the spread of bacteria.

According to Bloomberg Businessweek, the U.S. Department of Health and Human Services (HHS) want to start the program with some ten million first responders and their families, before expanding it to the rest of the population.

Anthrax is caused by a bacterium, Bacillus anthracis, which, as is the case with most bacteria, is capable of forming itself into a spore that can live for centuries. The contagion occurs by direct contact with the spores rather than by contact with an infected organism, unless the infected organism is also carrying spores.

Anthrax in humans  largely shows up in three forms.

Most common is cutaneous, or skin-level, in which the spores are introduced into the host tissue via an open wound. It begins as a lesion with a black dot in the center, which gradually expands in size with no associated pain. Gradually, the black center (from which the disease gets its name: its resemblance to anthracite coal) expands and there is some swelling .Even without treatment, only 20 percent of cases result in toxicity and death. It is easily recognized, treated, and cured.

The rarest form of anthrax infection is gastrointestinal, which is usually acquired by the consumption of infected meat. Once the bacterium enters the bowel system, it spreads throughout the body via the bloodstream, producing toxins all the way along. It is treatable, but fatality rates range from 25 percent to 60 percent, depending on when treatment begins.

The most lethal form of anthrax infection is pulmonary. Once infected by the spores, the host develops flu-like symptoms for three to five days, followed  by severe respiratory collapse. If treated early, as in the 2001 anthrax attacks, mortality falls to about 45 percent, compared to 92 percent in the infection is untreated. Avoiding delays in treatment is thus of primary importance: if the disease is allowed to progress to its fulminant phase, mortality increases to 92 percent.

The FDA scrutiny centers around two main issues. The first is misuse of the kit-included doxycycline, which may well lower its efficacy against anthrax. Misuse, as in using the anti-biotic for other than its intended anti-anthrax purpose, may allow the anthrax bacillus to develop a resistance to the drug, making it more lethal.

The second concern is that distributing the kits to the general population may cause a panic, a fear on the public’s part that an anthrax attack is imminent.

In 2007 the Centers for Disease Control tested the possible outcome when it distributed, according to Bloomberg Businessweek, anti-anthrax kits to 4,076 households in the St. Louis area.

At the end of the study, 130 of those did not return their medkits. Most who did not return them lost the products or threw them away, while four households used them and five refused to return them, according to the report from the bioterrorism agency. One elderly woman took the doxycycline during an emergency declared for a snow storm, two used the tablets to treat sore throats, and one declined to specify the use, according to Linda Neff, a senior epidemiologist in the CDC office of public health preparedness and response, said during the FDA meeting.